Menu
Not yet recruiting NCT07506590

Association Between Periodontitis and Chronic Kidney Disease

Observational Periodontitis Chronic Kidney Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Periodontitis, Chronic Kidney Diseases. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Association Between Periodontitis and Chronic Kidney Disease: An Oral-Renal Axis Study With Exploratory Gut Microbiota Analysis

Overview

The goal of this observational study is to explore the comorbid association between periodontitis and chronic kidney disease (CKD) based on the oral-renal axis in adults aged 18 to 75 years. The main question it aims to answer is: Is periodontitis associated with chronic kidney disease through oral-renal axis-related mechanisms? Participants aged 18 to 75 years will be recruited and undergo clinical assessment, sample collection, and laboratory testing as part of the study. Periodontal status, kidney function, and oral microbiota characteristics will be evaluated to investigate the association between periodontitis and CKD. Fecal samples will also be collected for exploratory analysis of gut microbiota to assess its potential relevance to the oral-renal relationship.

Detailed description

This observational case-control study with a cross-sectional design aims to investigate the association between periodontitis and chronic kidney disease in adults aged 18 to 75 years. Participants will be classified into four groups according to the presence or absence of periodontitis and chronic kidney disease: PD(+)/CKD(-), PD(+)/CKD(+), PD(-)/CKD(+), and PD(-)/CKD(-). Periodontal examination, renal function assessment, and biospecimen collection will be performed. Oral samples will be analyzed to characterize oral microbiota, and fecal samples will be collected for exploratory gut microbiota analysis. The study aims to explore the oral-renal association and the potential relevance of gut microbiota to this relationship.

Primary outcome measures

  • Oral microbiota composition [Time frame: At baseline]
Secondary outcome measures (3)
  • Periodontal status [Time frame: At baseline]
  • Renal function [Time frame: At baseline]
  • Gut microbiota composition [Time frame: At baseline]

Eligibility criteria

Inclusion Criteria Disease Group: 1. Adults aged 18 to 75 years; 2. No restrictions on sex or race; 3. Diagnosis of at least one target disease, including periodontitis or chronic kidney disease; 4. Ability and willingness to provide written informed consent; 5. Ability to understand the study procedures and comply with study requirements.

Control Group: 1. Adults aged 18 to 75 years; 2. No restrictions on sex or race; 3. No history of diagnosis of periodontitis or chronic kidney disease; 4. Ability and willingness to provide written informed consent; 5. Ability to understand the study procedures and comply with study requirements.

Exclusion criteria

1\. Age <18 years or >75 years; 2. Pregnancy or lactation; 3. Current smoking, alcohol abuse, or betel nut chewing; 4. Unhealthy dietary habits, such as frequent intake of high-salt or high-fat foods; 5. Use of antibiotics or probiotics, or receipt of oral/gastrointestinal surgery, within the past 2 months; 6. Fewer than 8 natural teeth remaining; 7. Severe systemic diseases other than the target condition, mental illness, or other conditions that may affect study participation, compliance, or data interpretation; 8. Inability to understand the study procedures; 9. Current participation in another clinical trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07506590 · 2025-XJKQIEC-KY-QT-0003-003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗